On Wednesday, 24 April, the European Parliament voted in favour of the European Health Data Space (EHDS). This is a key step to unlock digital health across the European Union and beyond. The EHDS will empower patients and enable more precise and personalised healthcare for improved outcomes across the care spectrum.
The co-legislators’ commitment during the file’s negotiations has strengthened the legislation. This is especially the case regarding the compromise achieved on the opt-out mechanism that recognises citizens’ right to choose whilst also generating representative and quality data for research. This agreement also improves the digital environment for the testing and certification of electronic health record systems – which aims to avoid bottlenecks caused by third party certification – and enhances support for health professionals’ training and patients’ digital health literacy.
Certain additional elements, namely: greater clarity regarding the definitions of categories of data within scope of secondary use; the exclusion of pre-clinical/exploratory data (eg exploratory research datasets generated by private and public entities to inform early research and development which are not protected by intellectual property rights (IPR)) from secondary use; and more data holder rights around IPR and trade secrets, could have streamlined processes, reduced uncertainty for industry conducting R&D in Europe and strengthened the file.
While the regulation lays a strong foundation, as per the Letta report, there is more to be done, especially to prevent fragmentation during its implementation. The American Chamber of Commerce to the EU remains a committed partner in the digitalisation of the European healthcare landscape, and we will continue to support the EHDS, with keen interest from our member companies to participate in pilot projects.
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